Systems for administering medication

ABSTRACT

The autoinjector systems disclosed herein provide in part devices for allowing patients with reduced joint strength to more easily administer medicine. Certain exemplary syringe embodiments include a housing, a syringe assembly slidably mounted on the housing, and a needle cap releasably engaged to the housing, where the cap includes a protruding pocket for receiving a needle cap remover.

RELATED APPLICATIONS

This application claims the benefit of priority of U.S. provisionalapplication Ser. No. 61/135,262 filed Jul. 18, 2008, and U.S.provisional application Ser. No. 61/192,551 filed Sep. 18, 2008. Thedisclosures of each of the foregoing applications are herebyincorporated by reference in their entirety.

BACKGROUND

Rheumatoid arthritis (“RA”) is an autoimmune disease characterized bychronic inflammation of the joints leading to progressive cartilagedestruction and bone erosion. Patients with RA often suffer frominflamed joints with joint pain, stiffness, and swelling. More advancedforms of inflammation may cause the joint to lose its shape, alignment,and movement. RA has been treated for many years with a variety ofmedicines such as steroids and disease modifying antirheumatic drugs(DMARDs). Some of these drugs are administered through injections orinfusions. However, it is difficult for RA patients with compromisedjoint strength and mobility to manipulate available syringes to performa self injection, particularly for viscous biologics and other drugs.Currently, some drugs are injected using conventional hypodermicsyringes with a small needle cap. The conventional syringes aregenerally small, which makes holding or manipulating the syringe moredifficult. Many of these syringes also do not provide patients withsatisfactory handling and gripping structures.

In addition, typical syringes are difficult for some patients to de-capand re-cap. Such syringes are difficult to manipulate, particularlypatients suffering from joint swelling and pain as they must force theirfingers to close in around a small needle cap to manipulate the cap.

Some medications are injected using an autoinjector. Standardautoinjectors include a small pen-cap like cap that houses a rubberneedle cover that shields the needle of the device. Exemplaryautoinjectors available today include HUMIRA® Pen and Enbrel SureClick®.However, in certain instances, the cap, when disengaged by the patient,fails to remove the rubber needle cover shielding the needle of thedevice. The patient then attempts to remove the rubber needle cover,which may lead to accidental needle stabs. As one can imagine, failingto remove the rubber needle cover exposes the patient to great dangerand inconvenience. Certain autoinjectors also house the medicationwithin an enclosed housing and do not provide a mechanism for viewingthe volumetric level or color of the medication inside, therebyimpairing the patient from confirming whether or not the rightmedication level is included in the autoinjector.

A more user friendly medication administering system is needed toaddress these and other problems posed by currently availableautoinjector systems. There is a particular need for an autoinjectorsystem that allows a patient to more easily administer a viscous drug,yet still provide increased safety as well as increased control. Thereis also a need for an autoinjector system that provides more ergonomiccap removing capabilities for patients with joint pain.

SUMMARY OF THE INVENTION

The autoinjector system disclosed herein addresses various deficienciesin the prior art by providing, in various aspects and embodiments, animproved autoinjector system that allows patients to more easilyadminister medicine, particularly patients with compromised dexterity orjoint strength. In one representative embodiment, an autoinjector deviceis provided with a housing, a syringe assembly that is slidably mountedon the housing and having a needle and a fluid container, anautoinjector actuator for urging the syringe assembly with respect tothe housing from a storage position to a launch position, and animproved cap that releasably engages with the housing. The cap includesa protruding pocket for receiving a needle cap remover. Exemplary needlecap removers include a connector having a base, a plurality of firstlegs spaced symmetrically away from one another and extending proximallyfrom the base, and a plurality of second legs extending proximally fromthe base and having a tip that flares outwardly towards the protrudingpocket. At least one of the second legs is positioned between two of thefirst legs.

In certain embodiments, a first leg includes internally facing barbsthat engage a needle shield that covers the needle of the syringeassembly. In certain embodiments, the internally facing barbs include atip that flares inward and towards the base. In certain embodiments, thetip of at least one of the first legs dig into the needle shield. Thetip of at least one of the second legs engages the protruding pocket. Incertain embodiments, the internally facing barbs are concaved. Theinternally facing barbs may also extend at an angle with respect to theupright. In certain embodiments, at least one of the first legs includesan upright and a first pair of internally facing barb tips positioned toa lateral side of the upright and a second pair of internally facingbarb tips positioned to a medial side of the upright.

According to one implementation, an autoinjector device includes ahousing having distal and proximal ends, the distal end including aninterfacing passage that receives a needle cap. The needle capreleasably engages with the housing and has a protruding pocket forreceiving a needle cap remover. In certain implementations, a syringeassembly is provided that slidably mounts on the housing and includes aneedle and a fluid container. Exemplary implementations also include anautoinjector actuating mechanism disposed on the housing for urging thesyringe assembly with respect to the housing from a storage position toa launch position, where when the syringe assembly is in the storageposition, the protruding pocket of the cap extends through theinterfacing passage, and when the syringe assembly is in the launchposition, the needle of the syringe assembly extends through theinterfacing passage. In certain embodiments, the autoinjector deviceincludes a needle cap remover having a connector that includes a base, aplurality of first legs spaced symmetrically away from one another andextending proximally from the base, and a plurality of second legsextending proximally from the base and having a tip that flaresoutwardly towards the protruding pocket. At least one of the second legsis positioned between the plurality of the first legs. In certainembodiments, the connector receives a needle cover. In certainembodiments, the autoinjector actuating mechanism includes a spring. Incertain embodiments, the cap covers about half of the length of thedevice.

In certain embodiments, the needle cap includes closed and open ends,where the needle cap includes a clear window disposed between the closedand open ends. The housing may also include a corresponding windowpositioned beneath the clear window of the needle cap when the cap isengaged to the housing. In certain embodiments, the needle cap includeslongitudinal ribs extending along the length of the cap. Thelongitudinal ribs may also extend within the needle cap. Thelongitudinal ribs may be spaced apart so that at least one rib extendson one side of a clear window and at least one rib extends on anotherside of the clear window. In certain embodiments, the needle capincludes a curved interface and the housing includes a correspondinginterface adapted to mate with the curved interface of the needle cap.

BRIEF DESCRIPTION OF THE DRAWINGS

The following Figures depict illustrative embodiments of the inventionin which like reference numerals refer to like elements. These depictedembodiments may not be drawn to scale and are to be understood asillustrative and not limiting.

FIG. 1A depicts a perspective view of an autoinjector system in astorage position according to an illustrative embodiment of theinvention.

FIG. 1B depicts an exploded view of the autoinjector system shown inFIG. 1A.

FIGS. 2A-2D depict perspective views of an elongate cap disengaging froma housing of the autoinjector depicted in FIG. 1A.

FIGS. 3A-3D depict various views of an exemplary embodiment of anelongate cap of the autoinjector depicted in FIG. 1A.

FIG. 4 shows a perspective view of an elongate cap being removed from ahousing of the autoinjector depicted in FIG. 1A.

FIGS. 5A-5C depict inside, side, and perspective views of a lowerhousing of the housing as depicted in FIG. 4.

FIG. 5D depicts a housing having a window that displays the medicationcontained within a syringe assembly disposed within the housing.

FIGS. 6A-6C depict various views of an elongate cap engaging a lowerhousing of the autoinjector according to an illustrative embodiment ofthe invention.

FIG. 6D shows a perspective view of an autoinjector in a storageposition with a cross sectional (cut away) view of the distal region ofthe autoinjector.

FIGS. 6E-6F depict longitudinal and transverse cross sectional views ofan elongate cap engaging a lower housing according to an illustrativeembodiment of the invention.

FIG. 7A depicts a perspective view of a housing according to anillustrative embodiment of the invention.

FIG. 7B shows perspective views of the housing shown in FIG. 7A and anelongate cap.

FIG. 8 shows a perspective view of an exemplary embodiment of a housingin a launch position.

FIG. 9A depicts a cross sectional view of the elongate cap engaging adistal region of a lower housing according to an illustrative embodimentof the invention.

FIG. 9B depicts an exploded view of an exemplary embodiment of a needleshield and a needle shield housing being engaged to an elongate cap.

FIGS. 10A-10B depict perspective and cross sectional views of anexemplary embodiment of the needle shield depicted in FIG. 9B.

FIGS. 11A-11B depict perspective and cross sectional view of anexemplary embodiment of the needle shield housing depicted in FIG. 9B.

FIG. 12 shows an exemplary embodiment of the needle shield being matedto the needle shield housing.

FIGS. 13A-13B show various views of the connector being inserted intothe elongate cap depicted in FIG. 9B.

FIG. 13C depicts an exemplary mating relationship between a needleshield housing, a connector, and an elongate cap.

FIGS. 14A-14C depict various views of an exemplary embodiment of aconnector for connecting the needle shield housing to the elongate capas depicted in FIG. 9B.

FIG. 15 depicts an exemplary mating relationship between a connector andan elongate cap.

FIG. 16 depicts an exemplary mating relationship between variouscomponents of an elongate cap assembly.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

To provide an overall understanding of the invention, certainillustrative embodiments will now be described, including exemplaryembodiments of a system that is adaptable to automatically inject drugsin the treatment of a patient suffering RA or other auto-immune diseasessuch as Multiple Sclerosis, Lupus, and Spondylitis. However, it will beunderstood by one of ordinary skill in the art that the systems andmethods described herein can be adapted and modified for other suitableapplications and that such other additions and modifications will notdepart from the scope hereof.

Turning to the illustrative embodiments, FIGS. 1A-1B show perspectiveand exploded views of an exemplary embodiment of an autoinjector system100. As shown, the autoinjector system 100 includes an elongate cap 102that is releasably secured to a housing 104. The housing 104 provides agrasping surface 412 to allow a patient to hold and inject themedication contained in the autoinjector system 100. As shown, theelongate cap 102 and the grasping surface 412 of the housing 104 havecontrasting finishes so the patient can easily identify the graspingsurface 412 from the elongate cap 102 that needs to be removed prior touse.

FIG. 1B is an exploded view of the autoinjector system 100 showing thehousing 104 ready to receive a syringe assembly 101 that is slidablymounted within the housing 104. The syringe assembly 101 includes aneedle 105 and a medication container 103. The housing 104 alsoincludes, among other things, an actuating mechanism 109 for urging thesyringe assembly 101 with respect to the housing 104 from a storageposition (FIG. 1) to a launch position (FIG. 8) to allow automaticdispensing of the medication contained within the syringe assembly 101.As shown, the actuating mechanism 109 is spring loaded, however, anytype of an energy source may be used with the device described herein.For example, a gas cylinder similar to the type used in a conventionalaerosol can or the like (i.e., having a valve through which gas can bereleased at will and in a controlled manner) can be used. Once mated,the syringe assembly 101 is completely enclosed within the housing 104and only the dosage marks 107 disposed on the medication container 103are visible from the outside (See FIG. 1).

As noted above, the elongate cap 102 is releasably engaged to thehousing 104 for shielding a portion of the housing 104 prior to use. Theelongate cap 102 is held onto the housing 104 via friction, thus a smallforce sufficient to overcome the holding friction is applied todisengage the elongate cap 102 from the housing 104. FIGS. 2A-2C showthe elongate cap 102 being disengaged from the housing 104 at variouspoints, which occurs as the elongate cap 102 is pulled distally awayfrom the housing 104 in a direction noted by Arrow A. As shown in FIG.2D, the elongate cap 102 has an open end 202 and a closed end 204 andincludes, among other things, a sleeve body 206 and a proximal rim 210positioned at the open end 202 of the elongate cap 102. As illustrated,the length of the elongate cap 102 extends substantially along the shaftof the autoinjector 100, covering up to about half of the length of theautoinjector 100 (FIG. 1). This allows a patient with joint pain to usea full hand grip to grasp and remove the elongate cap 102. Compared to ashorter or smaller cap, the longer length of the elongate cap 102 allowsthe patient to grasp more of the elongate cap 102 using various graspingtechniques to accommodate their reduced hand dexterity and/or strength.In certain embodiments, the elongate cap 102 is longer than about thehalf of the length of the autoinjector 100.

A patient holding the autoinjector 100, through the clear window 208,can visually check the drug (e.g., color or presence of other substancecontained within the syringe assembly) and its volumetric level. Asshown, the elongate cap 102 is semi-transparent on all areas other thanthe clear window 208. In some embodiments, the outer surface 207 of thesleeve body 206 has a frosted finish to hide the inner components, whichprovides an aesthetically pleasing look to the autoinjector. The frostedouter surface 207 also allows the patient to easily distinguish by feelthe elongate cap 102 from the housing 104 of the autoinjector 100. Incertain embodiments, the grasping surface 412 of the housing 104includes a rubber texture for providing friction when gripped by thepatient, which reduces slipping of the handle while the device is inuse.

FIGS. 3A-3D show various views of the elongate cap 102, an ellipticalcylinder, that has an elliptical cross section as shown in FIG. 3C. FIG.3A shows the elongate cap 102 having two clear windows 208 a and 208 bpositioned facing one another. This allows the patient to hold theautoinjector 100 and check the content of the autoinjector 100regardless of the direction that the autoinjector 100 is being held. Asshown in FIG. 3B, the clear window 208 a is disposed on the outersurface 207 between the open end 202 and the closed end 204 of theelongate cap 102. This window allows the patient to inspect the contentdisposed beneath the clear window 208 a. The patient can inspect thedrug prior to and without having to disengage the elongate cap 102 fromthe housing 104, thereby reducing the risk of contamination that mightotherwise occur if the patient removed the cap to view the contents ofthe injector. It may also reduce the likelihood of the patientaccidentally stabbing herself while checking the amount or presence ofthe drug contained within the housing while the cap is removed.

As shown in FIG. 3B, the clear window 208 a includes first and secondlongitudinal sides 302 a-302 b and first and second transverse sides 304a-304 b. The longitudinal sides 302 a 302 b taper towards one anotheralong Arrow A as they extend from the first transverse side 304 a to thesecond transverse side 304 b. The ends of the longitudinal sides 302a-302 b and transverse sides 304 a-304 b are curved so that the clearwindow 208 a has four rounded corners 306 a-306 d. The shape and thesize of the clear window 208 a may vary depending on the size and theshape of a drug containing compartment. For example, the clear windows208 a and 208 b may be rectangular, square, or oval in shape. In certainembodiments, the clear windows 208 a and 208 b are formed by removing asection of material of the sleeve body 206. In other embodiments, theclear windows 208 a and 208 b are made of a clear material such as glassor plastic to allow the patients to view contents underneath the clearwindows 208 a and 208 b.

An inside view of the elongate cap 102 having an elliptical crosssection is shown in FIG. 3C. The elongate cap includes major axis (or“diameter”) 301 and minor axis (or “diameter”) 303, where the majordiameter 301 is greater than the minor diameter 303. As shown, theelongate cap 102 includes two upper longitudinal ribs 310 a-310 b in anupper portion 201 of the elongate cap 102 and two lower longitudinalribs 310 c-310 d in a lower portion 203 of the elongate cap 102. Eachrib also includes a contacting surface 316 formed by two side surfaces318 and 320. With respect to the Axis A (FIG. 3C), the two upperlongitudinal ribs 310 a-310 b are disposed opposite the two lowerlongitudinal ribs 310 c-310 d. As shown in FIG. 3A, the longitudinalribs are spaced apart so that at least one rib extends on one side of aclear window 208 a and at least one rib extends on opposite side of theclear window 208 a. These longitudinal ribs 310 a-310 d help guide andsecure the elongate cap 102 to the housing 104 during the manufacturingassembly and also re-capping process, as discussed below.

As shown in FIG. 3D, which shows a cross sectional view of the elongatecap 102, the longitudinal ribs 310 a-310 d are disposed on an innersurface 110 of the elongate cap 102 and extend longitudinally along thelength of the elongate cap 102. Each longitudinal rib also includes atip 312 disposed near the proximal open end 202 and a base 314positioned near the closed distal end 204. Each longitudinal rib tapersgradually along the length of the elongate cap 102 from the base 314towards the tip 312. The thickness of the longitudinal rib thus variesalong the length of the elongate cap 102—the longitudinal rib near theclosed end 204 is thicker than near the open end 202. This difference inthickness enables the elongate cap 102 to secure itself to the housing104, as described more fully with respect to FIGS. 6E-6F.

As illustrated in FIG. 3D, the closed end 204 of the elongate cap 102 isrounded and tapers to a tip region 205. However, the shape of the closedend 204 of the elongate cap 102 may be of any shape that providesstructural support to the elongate cap 102. For example, the tip regionof the elongate cap may be flat to allow the patient to hold theautoinjector 100 against a flat surface such as a table.

FIG. 4 shows a perspective view of the elongate cap 102 disengaged fromthe housing 104 (without the syringe assembly, for viewing clarity). Asshown, the housing 104 includes an upper handle 402 for providing thegrasping surface 412 and a lower housing 404 that encases the syringeassembly 101 (not shown). The lower housing 404 includes a distal end410 and a proximal end 408 that interfaces with the upper handle 402 asdescribed below.

FIGS. 5A-5C show various views of the lower housing 404 having majordiameter 430 and minor diameter 432, where the major diameter 430 islonger than the minor diameter 432. As shown, the lower housing 404 istapered from the proximal end 408 to the distal end 410. The major andthe minor diameters gradually increase from the distal end 410 towardsthe proximal end 408. The lower housing 404 includes two cut out windows434 a and 434 b, positioned beneath the elongate cap 102, through whichthe syringe dosage markings can be viewed. The cut out windows 434 a and434 b align with the clear windows 208 a and 208 b when the elongate cap102 is fully engaged to the lower housing 404. As noted above, the clearwindows 208 a and 208 b of the elongate cap 102 allow the patient to seethrough the window and check the drug contained beneath.

As illustrated in FIG. 5C, the cut out window 434 a includes a pluralityof longitudinal side surfaces 436 a-436 b, a proximal transverse sidesurface 438 b, and a distal transverse side surface 438 a. Each of thesesurfaces extends from the outer surface 418 to the inner surface 419 atan angle. FIG. 5D shows the syringe assembly 101 fitted within the lowerhousing 404 and shows the plurality of longitudinal and transverse sidesurfaces 436 a-436 b and 438 a-438 b extending at an angle. As shown,the longitudinal sides surfaces 436 a-436 b taper towards one anotheralong Arrow 435 as they extend from the proximal transverse side surface438 b to the distal transverse side surface 438 a, corresponding inshape with the clear window 208 a of the elongate cap 102. Asillustrated, the surfaces 436 a-436 b and 438 a-438 b are connected toone another to form a single contiguous surface 437 extending around thedrug containing portion of the syringe assembly 101. It will beunderstood by one of ordinary skill in the art that the shape and thesize of the cut out window 434 may vary depending on the size and theshape of a drug containing compartment and the corresponding clearwindow disposed on the elongate cap 102.

In addition to the elongate cap having features discussed above, animproved cap having self-alignment capability is disclosed herein. Insome instances, patients attempt to re-cap the elongate cap 102 to thehousing 104 after use, even if advised not to do so. Therefore, it isbeneficial to have features that allow the patients to more easilymanipulate the elongate cap 102 with minimal effort to align theelongate cap 102 with respect to the housing 104. The elongate cap 102self aligns and secures itself to the lower housing 404 of the housing104 so that the proximal rim 210 aligns with the distal rim 420 on theupper handle 402 (See FIG. 4). FIGS. 6A-6F illustrate the elongate cap102 engaging the lower housing 404 to create this alignment.

FIG. 6A shows a cross sectional view of the elongate cap 102 initiallyengaging the lower housing 404. More specifically, the inner surface 110of the elongate cap 102, near the open end 202 of the elongate cap 102,loosely friction fits with the outer surface 418 of the lower housing404 near the distal end 410. Because the elliptical cross sectional areaof the lower housing 404 near the distal end 410 is smaller than theelliptical cross sectional area of the elongate cap 102 near the openend 202, the elongate cap 102 is initially loosely overlaid, with evensome rotational movement, with respect to the lower housing 404,temporarily misaligning proximal rim 210 of the elongate cap 102 anddistal rim 420 of the upper handle 402. As an illustration, FIG. 6Bshows a transverse cross sectional view across plane A depicted in FIG.6A, which shows distance d₁ as a space between the contacting surfaces316 a-316 d of the elongate cap 102 and the outer surface 418 of thelower housing 404. In this configuration, the elongate cap 102 is ableto rotate with respect to the lower housing 404 and the contactingsurfaces 316 a-316 d of the longitudinal ribs 310 a-310 d do not yetmake contact with the outer surface 418 of the lower housing 404, butthe outer surface 418 gradually flares outwardly towards the upperhandle 402 from the distal end 410 (FIG. 6A). Thus, as the elongate cap102 is pushed proximally onto the lower housing 404, a right side pairof the longitudinal ribs (formed by the ribs 310 a and 310 d) and/or aleft side pair (formed by the ribs 310 b and 310 c) impedes the elongatecap 102 from rotating freely and keeps the elongate cap 102 on trackwhile the cap 102 is pushed towards the upper handle 402. Morespecifically, the right and left pairs of the longitudinal ribs contactthe regions P_(A) to P_(d) of the flaring outer surface 418, whichspatially restricts the elongate cap 102 and prevents it from rotatingin the direction R (FIG. 6B), thereby maintaining the orientation of theelongate cap 102 with respect to the lower housing 404. Because the leftand right side pairs are spaced on left and right sides of the elongatecap 102, the center region 211 of the proximal rim 210 (FIG. 4) isautomatically aligned along the center region 415 (FIG. 6B) of the outersurface 418 of the lower housing 404, thereby being positioned to engagethe distal rim 420 of the upper handle 402 for mating upon closure.

FIG. 6C shows a perspective view of the elongate cap 102 partiallycovering the lower housing 404 in the course of forming the alignment.As the elongate cap 102 moves closer to the upper handle 402, theproximal rim 210 of the elongate cap 102 and the corresponding distalrim 420 of the upper handle 402 help orient the elongate cap 102 withrespect to the upper handle 402. A contoured mating interface 500 (FIG.6D) is formed when the proximal rim 210 of the cap 102 and thecorresponding distal rim 420 of the upper handle 402 are fully mated toone another.

Referring again to FIG. 6C, the proximal rim 210 of the elongate cap 102includes a lower trough 322 and an upper extension 324. These mate witha corresponding lower extension 422 and a corresponding upper trough 424of the distal rim 420. The curves of the troughs and extensions are soconfigured to force the troughs 322 and 424 to move toward theirrespective mating extensions 422 and 324 like a puzzle, thereby seatingthe mating surfaces 326 and 426 of the elongate cap 102 and the upperhandle 402 so that they sit flush with one another. Until that occurs,when the cap 102 is completely on, the elongate cap 102 may be able torotate slightly with respect to the handle 402. But once the matingsurfaces 326 and 426 make full contact against one another, the elongatecap 102 is unable to twist or move with respect to the upper handle 402until a disengaging force is applied. In such full contactconfiguration, the cut out window 434 of the lower housing 404 isaligned beneath the clear window 208 of the elongate cap 102. FIG. 6Ddepicts an exemplary embodiment of such positioning between the clearwindow 208 of the elongate cap 102 and the cut out window 434 of thelower housing 404.

During the course of aligning the elongate cap 102 along the lowerhousing 404, the contacting surfaces 316 a-316 d also help secure theelongate cap 102 to the lower housing 404. When the contacting surfaces316 a-316 d engage the outer surface 418 of the lower housing 404, thefriction created between contact surfaces 316 a-316 d and the outersurface 418 holds the elongate cap 102 against the lower housing 404.That contact prevents the elongate cap 102 from slipping and helps holdthe elongate cap 102 in position until the proximal rim 210 of theelongate cap 102 and the distal rim 420 of the upper handle 402 fullyengage one another. FIGS. 6E and 6F illustrate this contact with respectto the contacting surface 316 a engaging the lower housing 404 while theelongate cap 102 slides against the flaring outer surface 418. As shown,as the elongate cap 102 is pushed towards the upper handle 402, largerportions of the contacting surfaces 316 a and 316 c make contact withthe flaring outer surface 418 as shown in FIG. 6E (contact region C). Asa result, the friction created between the contacting surfaces 316 a-316d and the outer surface 418 increases, which provides more secure fitbetween the elongate cap 102 and the lower housing 404. FIG. 6F shows atransverse cross sectional view across plane B as depicted in FIG. 6E.As shown, the contacting surfaces 316 a-316 d near the base 314 are infull contact with the outer surface 418 of the lower housing 404. As thepatient continues to slide the elongate cap 102 along the flaring outersurface 418 towards the upper handle 402, thereby closing the gap 600shown in FIG. 6E, the patient may feel increasing resistance as thecontact friction between the contacting surfaces 316 a-316 d and theouter surface 418 continues to increase until the proximal rim 210 andthe distal rim 420 engage one another. The feel of the increasingfriction, together with the alignment of the proximal 210 and distalrims 420, provide a guide for the patient to more easily reapply thecap.

In certain embodiments, the autoinjector system of the invention alsoprovides a more ergonomic and efficient interface between lower housing404 and the elongate cap 102, as shown in FIGS. 7A-7B. FIG. 7A shows aperspective view of the distal end 410 of the lower housing 404. Asshown, the distal end 410 of the lower housing 404 includes a large skincontacting surface 440 that contacts the patient's skin when the deviceis in use. The outer diameter 448 near the distal end 410 is largeenough to make contact with the longitudinal ribs 310 a-310 d of theelongate cap 102. When the device is in use, the force applied by theautoinjector 100 spreads throughout the skin contacting surface 440,thereby more evenly distributing the force to help ease the patientcomfort's level. In certain embodiments as illustrated in FIG. 7A, theskin contact surface 440 has a doughnut shape.

As shown in FIG. 7B, the distal end 410 of the lower housing 404 is alsoprovided with an opening, also referred to as an interfacing passage444. When in use, the autoinjector fires and the needle 105 extendsthrough the interfacing passage 444 to inject the medication, thenretreats back through interfacing passage 444. When not in use, theinterfacing passage 444 receives the connector housing pocket 120 of theelongate cap 102 to shield the patient from the needle. The connectorhousing pocket 120 is secured within the interfacing passage 444 as aninterior receiving surface 446 of the lower housing 404 engages with acorresponding mating surface 146 of the connector housing pocket 120 infriction fit. The corresponding mating surface 146 engages with aportion of the receiving surface 446 of the lower housing 404. When theelongate cap 102 is removed from the lower housing 404, the matingsurface 146 disengages from the interior receiving surface 446, whichclears the interfacing passage 444 to allow the needle 105 of thesyringe assembly 101 to extend through for injection. FIG. 8 shows anexemplary embodiment of the needle 105 extending through the interfacingpassage 444 when the device is in a launch position. Thus, theinterfacing passage 444 is sized and shaped so as to receive a portionof the elongate cap 102, when the device is in a storage position, andthe syringe assembly 101 when the device is in use.

FIG. 9A depicts a cross sectional view of the elongate cap 102 beingmated to the lower housing 404 when the autoinjector is in a storageposition. It also shows the connector housing pocket 120 being joined tovarious other components that protect the needle 105 of the syringeassembly 101. These components, which form an elongate cap assembly 1000when joined to one another, are shown in FIG. 9B. The elongate capassembly 1000 includes a rubber needle shield 601 for shielding theneedle of the syringe assembly 101, a needle shield housing 602 thatgrips the outer surface 615 of the rubber needle shield 601, and aconnector 604 that grips the outer surface 613 of the needle shieldhousing 602. The connector 604 is friction fitted along its exteriorsurface 611 within the connector housing pocket 120 of the elongate cap102. These components and their mating relationships are explainedbelow.

FIGS. 10A and 10B depict perspective and cross sectional views of anexemplary embodiment of the rubber needle shield 601. As shown, therubber needle shield 601 is cylindrical in shape and includes a shoulder1002 near a proximal end 1001. The rubber needle shield 601 alsoincludes a needle receiving portion 1004 that houses the needle. Theneedle receiving portion 1004 tapers towards a distal end 1003. Therubber needle shield 601 also includes a needle tip holding portion 1006that extends from a tip 1005 of the needle receiving portion 1004towards the distal end 1003. The tip holding portion 1006 houses the tipof the needle. In certain embodiments, the rubber needle shield 601 ishollow.

Referring again to FIG. 9B, the rubber needle shield 601 fits within thespace 605 of the needle shield housing 602. As shown in FIGS. 11A-11B,the needle shield housing 602 includes open windows 1102 a and 1102 bdisposed on the outer surface 613 near an open end 1101. As the rubberneedle shield 601 is inserted into the space 605 of the needle shieldhousing 602, the shoulder 1002 of the rubber needle shield 601 havingthe largest diameter is squeezed into the space 605 until the shoulder1002 clicks within the open windows 1102 a and 1102 b. FIG. 12illustrates an exemplary embodiment of the rubber needle shield 601being fitted within the needle shield housing 602, forming a needleshield assembly 900. A conventional hypodermic syringe assembly (forexample, a syringe assembly manufactured by Becton, Dickinson andCompany) may also be used with the autoinjector described herein. Theneedle shield housing 602 may be made of plastic material or othermaterial that provides structural support to the rubber needle shield601. The needle shield assembly 900 is fitted within the connector 604,which is fitted within the elongate cap 102 as described more fullybelow.

The connector 604 includes a number of features for securing the needleshield assembly 900 to the elongate cap 102. FIG. 13A shows an explodedview of the connector 604 being inserted within the elongate cap 102(shown in cross sectional view for viewing clarity). As shown, theconnector housing pocket 120 with a circular cross section includes aclosed end surface 122 and an open end 124. The connector 604 slideswithin the open end 124 of connector housing pocket 120. The connector604 includes a base 705, a plurality of first legs 702 a-702 d, spacedsymmetrically away from one another near the proximal end 720 of theconnector 604, that engage the needle shield assembly 900. The connector604 also includes a plurality of second legs 706 a-706 b that extendproximally from the base 705 and having barb tips 707 a-707 d that flareoutwardly.

The connector 604 is initially flower shaped, as illustrated in FIG.14A-14C, but is bent so as to be confined within a cylindrical shapedstem 126 (FIG. 13A) of the connector housing pocket 120. As a result,the plurality of first legs 702 a-702 d, which were initially disposedat an angle with respect to the horizontal are now about 90 degrees withrespect to the horizontal (See FIGS. 13B and 13C), thereby applying aninterference force (Arrow C as shown in FIG. 13C) against the outersurface 613 of the needle shield housing 602 when the needle shield 602is received within the connector 604. More specifically, as shown inFIG. 13C, each of the first legs (e.g., 702 a) includes two upperinternally facing barbs (e.g., 703 a-703 b). The upper internally facingbarbs 703 protrude inwardly and distally to receive and grip the outersurface 613 of the needle shield housing 602. FIG. 13C depicts a crosssectional view of the connector 604 engaging the outer surface 613 ofthe needle shield housing 602. The upper, internally facing barbs 703are adapted to receive with minimal interference the needle shieldhousing 602 when the needle shield housing 602 is being inserted ontothe connector 604 in the direction indicated by Arrow A. As shown, theinternally facing barbs 703 are disposed at an angle such that theneedle shield housing 602 slides onto the internally facing barbs 703when it is first inserted into the connector 604. However, once engaged,upper, internally facing barbs 703, which are protruding inwardly anddistally, are shaped to engage the outer surface 613 of the needleshield housing 602 and prohibit backsliding (Arrow B) of the needleshield housing 602 or removal of the connector 604 from the needleshield housing 602. As shown, the upper, internally facing barbs 703a-703 h include tips 704 a-704 p that point toward the base 705 of theconnector 604. These tips 704 a-704 p of the upper, internally facingbarbs 703 a-703 h dig into the outer surface 613 of the needle shieldhousing 602. When the elongate cap 102 is pulled distally (Arrow A), thedistally applied force causes the tips 704 a-704 p of the upper barbs703 a-703 h to dig further into the outer surface 613 of the needleshield housing 602 as noted by Arrow C. This connection prevents theneedle shield housing 602 from separating from the elongate cap 102 whena patient pulls on the elongate cap 102 distally.

As shown in FIGS. 14A-14B, the upper, internally facing barbs 703 a-703h are concaved and include barb tips (e.g., 704 a and 704 b) that applyopposing force with respect to one another when they engage the needleshield housing 602 as the barb tips are disposed at two ends of aconcaved surface (e.g., upper, internally facing barbs 703). In someembodiments, the upper, internally facing barbs 703 a-703 h are disposedat an angle with respect to the body of the first legs 702 a-702 d. Thisis more particularly shown in FIG. 14B. Such configuration may enhancethe engagement between the needle shield housing 602 and the connector604 as added protrusion (i.e., angled disposition of the barbs 703 withrespect to the first legs 702) and allow the barb tips 704 a-704 p tomore securely dig into the outer surface 613 of the needle shieldhousing 602 when the patient pulls the elongate cap 102 distally. Asdepicted in FIG. 14B, the longitudinal axis 710 of the upper portion 711of the first legs 702 b is disposed at angle α with respect to thecenter axis 712 of the upper, internally facing barb 703 c. The centeraxis 712 may be disposed between about 3 degrees to about 30 degreeswith respect to the longitudinal axis 710 of the first legs 702 b. Insome embodiments, as illustrated in FIG. 14A, at least one of the firstlegs (e.g., 702 a) includes an upright 721 and a first pair ofinternally facing barb tips (e.g., 704 a-704 b) is positioned to alateral side of the upright 721 and a second pair of internally facingbarbs tips (e.g., 704 c-704 d) is positioned to a medial side of theupright 721. In some embodiments, the connector 604 is made by stampinga thin sheet of stainless steel and bending the first and second legsinto angles with respect to the horizontal. This allows for a costeffective manufacturing and mass production.

The connector 604 also includes the plurality of second legs 706 a-706 bthat are spaced symmetrically away from one another in the distal end ofthe connector 604. These second legs extend proximally from the base 705and include lower, externally facing barb tips 707 a-707 d that flareoutwardly toward the connector housing pocket 120 when the connector 604is fitted within the connector housing pocket 120. As shown in FIGS.14A-14C, a second leg (e.g., 706 a) is positioned between two of thefirst legs (e.g., 702 a and 702 b). In some embodiments, the secondplurality of legs 706 a-706 b are initially disposed more than 90degrees (e.g., about 91 degrees to about 120 degrees) with respect tothe horizontal. When the connector 604 is fitted within the connectorhousing pocket 120 as shown in FIG. 15, the plurality of second legs 706a-706 b engage with the inner surface 128 of the connector housingpocket 120. As shown in FIG. 15, the lower, externally facing barb tips707 a-707 d engage a lower, interior portion of the connector housingpocket 120, barbing the connector 604 to the elongate cap 102 in amanner similar to the connections between the upper, internally facingbarb tips 704 a-704 p and the needle shield housing 602 as describedabove. As the lower, externally facing barb tips 707 a-707 d extendproximally into the connector housing pocket 120 (Arrow A), these barbstips 707 a-707 d prevent the elongate cap 102 from disengaging from theconnector 604. In some embodiments, the lower, externally facing barbtips 707 a-707 d dig into the inner surface 128 of the connector housingpocket 120 and remain fixed in place during use.

FIG. 16 depicts a perspective view of the elongate cap assembly 1000,showing the rubber needle shield 601 being mated to the needle shieldhousing 602 (forming the needle shield assembly 900), and the connector604 receiving the needle shield housing 602 and being fitted within theconnector housing pocket 120 of the elongate cap 102. As noted above,the connector 604 fits within the connector housing pocket 120 andengages the needle shield assembly 900, connecting permanently to theneedle shield assembly 900 by the expanding force of the bent flowerlegs, such that the barbs engage and, if the elongate cap 102 is pulleddistally by the patient, the entire elongate cap assembly 1000(including the rubber needle shield 601 covering the needle) is removedas a unit. In some embodiments the needle shield housing 602 isasymmetrical in shape, which allows at least one pair of legs (e.g., 702a and 702 c) of the connector 604 to make contact with the outer surface613 of the needle shield housing 602 such that when the elongate cap 102is pulled, the elongate cap assembly 1000 is removed as a unit. In someembodiments, only one but not both pairs of legs connect with the needleshield housing 602.

In certain implementations, the autoinjector system 100 is provided tothe patient in a kit including the autoinjector system and an alcoholswab. In certain embodiments the autoinjector system 100 is pre-filledwith medication. In certain embodiments, the system 100 is packaged witha pre-filled syringe that is inserted within the system 100 prior tocommercial sale. The pre-filled syringe includes medication to be usedto treat RA. Particular examples of medication include viscousmedications containing proteins or peptides especially antibodies orfragments thereof, including pegylated antibody fragments. The systemsand methods may in particular be used to administer the pegylatedantibody fragment known as certolizumab pegol. The medication may be fortreatment of any disease or disorder, including for the treatment ofrheumatoid arthritis. In certain embodiments, the viscosity of theliquid medication is less than about 120 mPa·s (120 centipoise),preferably less than 100 mPa·s (100 centipoise) at a deliverytemperature of 20° C. In certain embodiments, the viscosity of theliquid medication is between about 65 centipoise and about 120centipoise. In certain embodiments, the viscosity of the liquidmedication is between about 75 centipoise and about 100 centipoise. Incertain embodiments, the viscosity of the liquid medication is higherthan about 65 mPa·s, preferably higher than 85 mPa·s. In certainembodiments the viscosity of the liquid medication is about 80centipoise. In certain embodiments, the liquid medication is designedfor refrigerated rest (e.g. at from 2-8° C.) and for injected deliveryat room temperature (e.g. at or about 18-30° C.). It is to be understoodthat while the invention has been described in conjunction with thevarious illustrative embodiments, the forgoing description is intendedto illustrate and not limit the scope of the invention. For example, avariety of systems and/or methods may be implemented based on thedisclosure and still fall within the scope of the invention. Forexample, the elongate cap described herein may be used with devicesdescribed in, for example, WO2005/070481, or other equivalent penneedles or autoinjectors for automatically injecting drugs to patients.Other aspects, advantages, and modifications are within the scope of thefollowing claims. All references cited herein are incorporated byreference in their entirety and made part of this application.

The invention claimed is:
 1. An autoinjector device comprising: ahousing; a syringe assembly slidably mounted on the housing, the syringeassembly including a needle and a fluid container; an auto injectoractuator for urging the syringe assembly with respect to the housingfrom a storage position to a launch position; a needle cap remover; anda cap releasably engaged to the housing, the cap having a protrudingpocket for receiving the needle cap remover; the needle cap removercomprising a connector having: a base; a plurality of first legs spacedsymmetrically away from one another and extending proximally from thebase, each first leg having an internally facing barb for receiving andengaging a needle cap that covers the needle of the syringe assembly;and a plurality of second legs extending proximally from the base, eachsecond leg having an externally facing barb tip that flares outwardlytowards the protruding pocket for engaging a lower, interior portion ofthe protruding pocket near the base, wherein at least one of the secondlegs is positioned circumferentially between two of the first legs, andwherein the plurality of second legs do not extend proximally from thebase as far as the plurality of first legs.
 2. The device of claim 1,wherein the internally facing barbs include a tip that flares inward andtowards the base.
 3. The device of claim 2, wherein the tip of at leastone of the first legs dig into the needle cap.
 4. The device of claim 1,wherein the internally facing barbs are concaved.
 5. The device of claim1, wherein at least one of the first legs includes an upright and afirst pair of internally facing barb tips positioned to a lateral sideof the upright and a second pair of internally facing barb tipspositioned to a medial side of the upright.
 6. The device of claim 5,wherein the internally facing barbs extend at an angle with respect tothe upright.
 7. A device comprising: a needle cap remover; a housinghaving distal and proximal ends, the distal end having an interfacingpassage that receives a cap; wherein the cap releasably engages thehousing and has a protruding pocket for receiving the needle capremover; a syringe assembly including a needle and a fluid container;and the needle cap remover comprising a connector having: a base; aplurality of first legs spaced symmetrically away from one another andextending proximally from the base, each first leg having an internallyfacing barb for receiving and engaging a needle cap that covers theneedle of the syringe assembly; and a plurality of second legs extendingproximally from the base, each second leg having an externally facingbarb tip that flares outwardly towards the protruding pocket forengaging a lower, interior portion of the protruding pocket near thebase, wherein at least one of the second legs is positionedcircumferentially between two of the first legs, and wherein theplurality of second legs do not extend proximally from the base as faras the plurality first legs.
 8. The device of claim 7, wherein the capcovers about half of the length of the device.
 9. The device of claim 8,wherein the housing includes a corresponding window positioned beneaththe clear window of the cap when the cap is engaged to the housing. 10.The device of claim 7, wherein the cap includes a clear window disposedbetween a closed end and an open end.
 11. The device of claim 7, whereinthe cap includes longitudinal ribs extending along the length of thecap.
 12. The device of claim 11, wherein the longitudinal ribs extendwithin the cap.
 13. The device of claim 11, wherein the longitudinalribs are spaced apart so that at least one rib extends on one side of aclear window and at least one rib extends on opposite side of the clearwindow.
 14. The device of claim 11, wherein the cap includes a curvedinterface and the housing includes a corresponding curved interfaceadapted to mate with the curved interface of the cap.